FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
10544-867
11-digit product format
105440867
Labeler code
10544
Product ID
10544-867_0f7d09d5-3e32-07a7-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA071196
Marketing category
ANDA
Marketing start
2014-05-22
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac7a3d9b-58c0-4ffc-a3eb-ed863453525eProduct name120250730
b2f15d64-48ea-ba98-af5c-91f410667b31Product name520250314
d8e7f61b-4ab5-0dbe-2706-4e11b6079b87Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-867-302020-01-31C16284748780-19d75b9d0-2c80-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE hydrochloride tablets, USP safely and effectively. See full prescribing information for TRAZODONE hydrochloride tablets, USP . TRAZODONE hydrochloride tablets , USP for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-867-30Trazodone Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-867-30EA - Each10544-867be9f4ef4-6cec-440b-8de1-6c8944460a2512015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-867TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150220_0f7d09d5-3e31-07a7-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856364traZODone HCl 150 MG Oral TabletPSN0f7d09d5-3e31-07a7-e054-00144ff8d46c1
856364trazodone hydrochloride 150 MG Oral TabletSCD0f7d09d5-3e31-07a7-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-867-301054408673030 in 1 BOTTLEHistorical